Guidance Documents - About Guidance

What is guidance?

Good Guidance Practice (GGP) documents are documents prepared for CDRH staff, regulated industry and the public that relate to:

the processing, content, and evaluation of regulatory submissions

the design, production, manufacturing, and testing of regulated products

the inspection and enforcement procedures

Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.